Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
Monoclonal Gammopathy of Renal Significance (MGRS)
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Jun 2025 → ongoing
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517676-37-01
- EudraCT number
- 2021-005856-12
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Monoclonal Gammopathy of Renal Significance (MGRS)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Kati Kaartinen
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Kati Kaartinen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2025-06-01 | 2025-06-02 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Finland | Acceptable with conditions 2025-01-28
|
2025-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-24 | Finland | Acceptable with conditions 2026-02-06
|
2026-03-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-21 | Finland | Acceptable 2026-04-29
|
2026-04-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-29 | Finland | 2026-04-29 |